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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K991564
Device Name JELTEMP
Applicant
J.F. Jelenko & Co., Inc.
99 Business Park Dr.
Armonk,  NY  10504
Applicant Contact RAPHAEL JUDKINS
Correspondent
J.F. Jelenko & Co., Inc.
99 Business Park Dr.
Armonk,  NY  10504
Correspondent Contact RAPHAEL JUDKINS
Regulation Number872.3770
Classification Product Code
EBG  
Date Received05/05/1999
Decision Date 06/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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